A Single-arm, Prospective, Phase II Clinical Study of the Combination of Entinostat and Oral Paclitaxel in the Treatment of HR+HER2- Advanced Breast Cancer

Phase 2Not Yet RecruitingNCT07441486

Tianjin Medical University Cancer Institute and Hospital50 enrolled

Overview

Objective: To explore the curative effect and safty of Changchun Ruibin metronomic chemotherapy combined with endistat in the treatment of HR positive HER2 negative advanced breast carcinoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

EntinostatDRUG

Entinostat will be administered according to the study protocol.

Oral PaclitaxelDRUG

Oral paclitaxel will be administered according to the study protocol.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Only participants who meet all of the following eligibility criteria will be eligible for this trial: * Age ≥ 18 years; * Patients with advanced breast carcinoma confirmed by histopathological and / or cytological examination; * HER2-negative breast carcinoma with confirmed HR positive primary and / or metastatic lesions; * At least one evaluable tumor lesion (according to RECIST1.1); * Prior 2-4 lines of therapy, which must include one endocrine therapy with CDK4 / 6 inhibitors, one chemotherapy with paclitaxel. * Previous 1L of ADC drug therapy is acceptable. * Complete clinical data on important research indicators; * The Eastern Oncology Assistance Group (ECOG) physical fitness status score was 0-2; * Life expectancy \> 6 months.

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS is defined as the time from first dose to first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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